Reducing Sedative Exposure in Ventilated ICU Patients

描述（由申请人提供）：机械通气是重症监护室（ICU）中最常用的高级生命支持方式，用于治疗各种原因引起的呼吸功能不全。为了减少焦虑、压力和提高对机械通气的耐受性，护士经常给这些患者使用镇静剂。虽然镇静有时是指，它不是没有严重的副作用，包括肌肉无力，精神状态的变化，长期的支持，并延长ICU停留。临床实践指南建议，在给予镇静剂之前，应尝试非药物策略以减轻患者的痛苦。然而，非药物策略未得到充分利用，并且在记录患者获益的临床试验中缺乏严格的评估。音乐是一种非药物干预，在单次治疗后显示出减少焦虑的希望，但缺乏对临床显著结果的严格评估。因此，本临床试验的主要目的是测试患者导向的音乐干预（PDM）对减少成人通气患者的镇静剂暴露和焦虑的影响，并检查伴随的对呼吸支持时间、ICU住院时间和压力调节的影响。将从中西部城市的5个ICU中招募186名接受急性呼吸支持的警觉患者样本，用于本3组重复测量的实验设计研究。接受辅助支持的受试者将被随机分配至PDM、降噪耳机或常规护理组，持续30天。每天采集镇静剂暴露量（总剂量和给药频率）、焦虑水平（视觉模拟量表和状态焦虑量表）和24小时尿皮质醇样本（应激）。主要数据分析将重复测量ANCOVA，控制疾病严重程度。本研究的长期目标是通过加强个人控制，同时减少镇静剂暴露及其严重副作用，对每年数百万经历机械通气的ICU患者的重要临床结局和生活质量产生积极影响。

DESCRIPTION (provided by applicant): Mechanical ventilation is the most frequently used advanced, life-supportive modality in intensive care units (ICUs) to treat respiratory insufficiency from a variety of causes. To reduce anxiety, stress and promote tolerance of mechanical ventilation, nurses frequently administer sedative agents to these patients. While sedation is indicated at times, it is not without serious side effects which include muscle weakness, mental status changes, prolonged ventilatory support, and extended ICU stay. Clinical practice guidelines suggest that non-pharmacologic strategies be tried to reduce patient distress before administering sedatives. However, non-pharmacologic strategies are under-utilized and lack rigorous evaluation in clinical trials that document patient benefit. One non-pharmacologic intervention that shows promise in reducing anxiety after a single treatment but lacks rigorous evaluation on clinically salient outcomes is music. Thus, the primary aim of this clinical trial is to test a patient-directed, as desired music intervention (PDM) on reducing sedative exposure and anxiety in adult ventilated patients, and to examine attendant influences on length of ventilatory support, length of ICU stay, and stress modulation. A sample of 186 alert patients receiving acute ventilatory support will be recruited from 5 ICUs in the urban Midwest for this 3 group experimental design study with repeated measures. Subjects receiving ventilatory support will be randomized to PDM, noise- canceling headphones, or to usual care for up to 30 days. Sedative exposure (aggregate dose and dose frequency), anxiety levels (visual analog scale and State Anxiety Inventory), and 24-hour urinary cortisol samples (stress) will all be collected daily. Primary data analysis will be repeated measures ANCOVA, controlling for illness severity. Long-term objectives of this study are to positively impact important clinical outcomes and quality of life for the millions of ICU patients who experience mechanical ventilation each year by enhancing personal control while reducing exposure to sedative agents and their serious side effects.